A safety and acceptability study of a vaginal ring microbicide delivery method for the prevention of HIV infection in women | ICRH

TEAM MEMBERS 

Dr. Stanley Luchters; Dr. Evans Malava; Dr. Jennifer Othigo; Dr. Kishor Mandaliya; Prof. Marleen Temmerman; Dr. Zoella Pasta; Ms. Wilkister Bosire; Ms. Caro Njeru; Ms. Elizabeth Makena; Ms.Victoria Oyier; Ms. GHrace Aketch; Ms. Agnes Karanja; Ms. Ekizabeth Sambo; Ms. Mary Wambo; Omar Mwakusema

PERIOD 

One Year

This is an open label crossover study conducted at 5 sites in South Africa (3 sites), Tanzania and Kenya amongst 200 healthy sexually active women aged 18-35 years. 50 participants will be enrolled per site to undergo two regimens over a 24 week period: vaginal ring and observational study (no vaginal ring). Approximately 20 women participants will participate in focus group discussions and 20 male partners in in-depth interviews. In Kenya, the study is carried out by ICRH at Mvita Municipal Clinic based in Mombasa.  The screening phase started in July 2007. Recruitment of potential participants is done through various family planning clinics and from the general community. In September, recruitment was enhanced through community mobilization outreach activities including women group health talks and drama. To date, 252 women have been seen at the clinic, 88 women have been screened and 45 women enrolled. Procedures conducted in different combinations during visits scheduled 2, 4, 8 and 12 weeks post enrollment, and 2,4, 8 and 12 weeks post cross-over involve general physical examination, pregnancy testing, STI screening and HIV-1 rapid testing; Counseling on HIV/STI Risk Reduction, vaginal ring adherence and contraception; cervico-vaginal sample collection for pap smear and ring acceptability questionnaire administration. Two women have so far exited the study and preparations for the qualitative phase of the study is underway.